Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors

November 14, 2023 updated by: Mayo Clinic

Assessment of Predicted LET and Dosimetry in Relation to White Matter Changes in Pediatric Patients Following Proton Therapy for Primary Central Nervous System and Base of Skull Malignancies: A Pilot Study

This trial gathers information from patients with primary central nervous system or base of skull tumors that receive proton beam therapy and see if certain imaging techniques can help detect radiation-related changes over time. This study may help providers learn more about proton beam radiotherapy and how to improve the way it is delivered.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To establish linear energy transfer (LET)-based models as early predictors for white matter changes on magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) sequences in pediatric patients following proton beam therapy for primary central nervous system (CNS) and base of skull tumors.

OUTLINE:

Patients' medical charts are reviewed.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic in Arizona
        • Contact:
        • Principal Investigator:
          • Tamara Z. Vern-Gross, D.O.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are diagnosed with central nervous system or base of skull malignancies, undergoing proton beam therapy

Description

Inclusion Criteria:

  • Patients must have histologically confirmed central nervous system of skull base tumors
  • Patient is going to undergo central nervous system (CNS) or base of skull proton beam therapy

Exclusion Criteria:

  • Patients who have received prior therapeutic radiotherapy to the primary brain tumor site
  • Patients who are unable to maintain follow-up through the Phoenix Children's Hospital and Mayo Clinic Arizona

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (medical chart review)
Patients' medical charts are reviewed.
Other: Medical Chart Review
Review of medical chart
Other Names:
  • Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences
Time Frame: At 18 months
The concordance of predicted linear energy transfer linear (LET) values with radiographic white matter changes will be analyzed utilizing a one sample t-test. Will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
At 18 months
White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences
Time Frame: At 18 months
The concordance of predicted LET values with radiographic white matter changes will be analyzed utilizing a one sample t-test. We will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
At 18 months
Relative biological effectiveness (RBE) predictions
Time Frame: Up to 18 months
Will compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White matter changes within the CNS following proton beam therapy using DTI and MRI
Time Frame: Up to 18 months
Will assess the white matter changes within the CNS following proton beam therapy using DTI and MRI and determine concordance with predicted RBE values and biological dose.
Up to 18 months
Dose-volume effect and predicted LET distribution
Time Frame: Up to 18 months
Will be correlated. Will evaluate the percent of concordance of isodose volumes with white matter changes utilizing pairwise t-tests and repeated measures mixed models.
Up to 18 months
White matter changes identified on imaging, and predict concordance
Time Frame: Up to 18 months
Will be described with both clinical acute and late toxicities following proton beam therapy. Exploratory analyses utilizing tests for association and appropriate regression techniques will be conducted to determine the association of dose volume histogram, LET, RBE, and clinical factors on acute and late toxicities caused by white matter changes.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Tamara Z. Vern-Gross, D.O., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Estimated)

June 21, 2026

Study Completion (Estimated)

June 21, 2026

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC1777 (Mayo Clinic in Arizona)
  • NCI-2020-01197 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 18-002279 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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